Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
  • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
  • A61B17/7002—Longitudinal elements, e.g. rods
  • A61B17/7019—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other
  • A61B17/7026—Longitudinal elements having flexible parts, or parts connected together, such that after implantation the elements can move relative to each other with a part that is flexible due to its form
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
  • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
  • A61B17/7002—Longitudinal elements, e.g. rods
  • A61B17/7011—Longitudinal element being non-straight, e.g. curved, angled or branched
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
  • A61B17/7053—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant with parts attached to bones or to each other by flexible wires, straps, sutures or cables
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
  • A61B17/7062—Devices acting on, attached to, or simulating the effect of, vertebral processes, vertebral facets or ribs ; Tools for such devices
  • A61B17/707—Devices acting on, or attached to, a transverse process or rib; Tools therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
  • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
  • A61B17/8869—Tensioning devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
  • A61B17/7001—Screws or hooks combined with longitudinal elements which do not contact vertebrae
  • A61B17/7035—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other
  • A61B17/7037—Screws or hooks, wherein a rod-clamping part and a bone-anchoring part can pivot relative to each other wherein pivoting is blocked when the rod is clamped
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
  • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
  • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
  • A61B17/70—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant
  • A61B17/7055—Spinal positioners or stabilisers, e.g. stabilisers comprising fluid filler in an implant connected to sacrum, pelvis or skull

Definitions

• Embodiments disclosed herein may be useful for preventing or slowing down the effects of adjacent level disease.
• the blocking body comprises a loop passage, an exit passage, an engagement portion, a closure member, and a compression member having a first surface.
• the loop portion of the conformable ligature passes through the loop passage and the first and second ends extend from the exit passage.
• the closure member engages with the blocking body in a manner to allow the first surface of the compression member contacting the conformable ligature to create a friction force between the conformable ligature and the blocking body.
• the blocking body connects the dynamic portion of the rod to the adjacent third vertebra to maintain motion of the adjacent third vertebra relative the first and second vertebrae and the first and second vertebrae are rigidly connected.
• FIGURE 8 is a partial cutaway view of an embodiment of a blocking body and conformable ligature coupled to a non-pedicle portion of a vertebra;
• the first and second vertebrae may be rigidly fixed to each other, and the second and third vertebrae may be dynamically fixed to each other to allow some movement between them.
• “coupled” components may directly contact each other or may be separated by one or more intervening members.
• Components of spinal stabilization systems may be made of materials including, but not limited to, titanium, titanium alloys, stainless steel, ceramics, and/or polymers. Some components of a spinal stabilization system may be autoclaved and/or chemically sterilized. Components that may not be autoclaved and/or chemically sterilized may be made of sterile materials. Components made of sterile materials may be placed in working relation to other sterile components during assembly of a spinal stabilization system. [0050] Spinal stabilization systems may be used to correct problems in lumbar, thoracic, and/or cervical portions of a spine. Various embodiments of a spinal stabilization system may be used from the C1 vertebra to the sacrum. For example, a spinal stabilization system may be implanted posterior to the spine to maintain distraction between adjacent vertebral bodies in a lumbar portion of the spine.
• the bending stiffness is produced by configuring the rod to provide a first bending stiffness that allows the initial range of spinal bending and a second bending stiffness that restricts spinal bending beyond the initial range of spinal motion.
• One way to achieve both the first bending stiffness and the second bending stiffness is to configure the opening of the rod to have a lower bending moment of inertia I (sometimes referred to as the second moment of inertia or the area moment of inertia) through the initial range of spinal motion and a higher bending moment of inertia beyond the initial range of spinal motion.
• longitudinal elements 20 and 22 may be positioned in an open configuration (or spaced-apart position), in which the threaded shank of closure member 106 is disengaged from bore 38.
• Ligature 14 may be passed or ligated around a non-pedicle portion of a vertebra and passed through loop passage 54 and out exit passage 40 of longitudinal elements 20 and 22 such that the vertebra is coupled to blocking body 105.
• Rod 104 may then be introduced into recesses 30 and 32 of longitudinal elements 20 and 22 so that strands 42 and 44 of ligature 14 are disposed between the inside wall of recesses 30 and 32 and the side face of rod 104. These two surfaces define passageway 48 for passing ligature 14 and having portions 42 and 44 of ligature 14 placed therein.
• ligature 14 Once ligature 14 is placed around the transverse process, a rib, a lamina, a portion of the posterior arc of a vertebra or the like, threaded shank of closure member 106 may be rotationally advanced into tapped bore 38, causing longitudinal element 22 to come progressively closer to longitudinal element 20.
• This approach simultaneously reduces the section of passageway 48 in which portions 42 and 44 of ligature 14 are engaged, and simultaneously introduces a coefficient of friction between ligature 14, rod 104 and walls of the recesses 30 and 32. Nevertheless, it is still possible for traction to be applied on the free ends 42 and 44 of ligature 14 until sufficient tension is obtained in ligature 14 around the non-pedicle portion of the vertebra.
• closure member 106 may be used to close blocking body 105 in a manner to hold ligature 14 in a relatively or completely stable position relative to blocking body 105.
• Closure member 106 of FIGURE 13 is shown having external threads 172 for engaging bore 38 in longitudinal member 20 of blocking body 105.
• closure member 106 may be positioned within longitudinal element 22 such that closure member 106 is free to rotate in longitudinal element 22 to join longitudinal element 22 with longitudinal element 20, but may not be removed from longitudinal element 22 after such engagement.
• FIGURE 17 depicts a side view of a portion of one embodiment of tensioning tool 250, which may be used to apply tension to conformable ligature 14 to engage rod 104, a portion of a vertebra, or some other device or bone.
• tool body 266 may include return spring
• first and second ends of ligature 14 may be disconnected from tensioning tool 250. Once ligature 14 has been disconnected from tensioning tool 250, tensioning tool 250 may be disengaged from blocking body 105.
• Various instruments may be used in a minimally invasive procedure to position bone fastener assemblies 102 in a patient for coupling rigid portion 104B of rod 104 to pedicles of a spine to form a part of a spinal stabilization system.
• the instruments may include, but are not limited to, positioning needles, guide wires, dilators, bone awls, bone taps, sleeves, drivers, tissue wedges, rod length estimating tools, tensioning tools, mallets, tissue retractors, and tissue dilators.
• the instruments may be provided in an instrumentation set.
• the instrumentation set may also include components of the spinal stabilization system.
• the components of the spinal stabilization system may include, but are not limited to, bone fastener assemblies of various sizes and/or lengths, rods, clamps, conformable ligatures and closure members.
• a targeting needle may be used to locate an entry point in a vertebral body for a bone fastener of a bone fastener assembly. Scale markings may be used to approximate a length of a bone fastener needed for a vertebra.
• a guide wire may pass down a shaft of a targeting needle outer housing.
• a guide wire may be from about 15 cm to about 65 cm in length. In some embodiments, guide wires provided in an instrumentation set are about 46 cm in length.
• the length of the guide wire may allow a surgeon and/or assistants to hold at least one portion of the guide wire at all times when the guide wire is inserted into vertebral bone, even during insertion, use, and removal of instruments along a length of the guide wire.
• a guide wire that can be held continuously during a surgical procedure may inhibit removal or advancement of the guide wire from a desired position during a minimally invasive surgical procedure.
• a mallet or other impact device may be used against a second end of the dilator so that the bone awl breaches cortical bone of the vertebra.
• the dilator may be removed from the bone awl and contact with the guide wire may be reestablished.
• a guide wire positioned in vertebral bone may be held near a top of a dilator inserted over the guide wire at a surgical site.
• a detachable member may be used as a guide to install bone fasteners of a bone fastener assembly in vertebral bone.
• a detachable member may be coupled to a collar of a bone fastener assembly.
• a distal end of a detachable member may be tapered or angled to reduce bulk at a surgical site. Instruments may be inserted into the detachable member to manipulate the bone fastener assembly. Movement of the detachable member may alter an orientation of a collar relative to a bone fastener of the bone fastener assembly.
• a detachable member may be used as a retractor during a spinal stabilization procedure.
• a multi-channel detachable member may be longer than a single-channel detachable member.
• a multi-channel detachable member may be at least about 15 cm long.
• a multi-channel detachable member may be about 16 cm long.
• Detachable members that are too long may require a longer incision and/or a larger tissue plane for insertion of a spinal stabilization system. Insertion of a rod may be more difficult with detachable members that are longer than necessary. Detachable members with excess length may be bulky and hard to manipulate during a surgical procedure.
• pressure supplied to a rod with a rod positioner may not be sufficient to seat the rod in a collar.
• a seater may be used in conjunction with a rod positioner to maneuver a rod into one or more collars.
• a rod positioner may be removed from the rod before using the seater.
• the rod positioner may remain attached to the rod until closure members are secured to bone fastener assemblies to form a spinal stabilization system.
• a user may apply downward force with handle 350 to seat the rod in a collar as the rod positioner is used to guide the rod into position.
• closure members may be used to secure the rod to the collars.
• the patient may be placed in a prone position on a radiolucent table with clearance available for a C-arm of a fluoroscope.
• a radiolucent table with clearance available for a C-arm of a fluoroscope.
• a Jackson table with a radiolucent Wilson frame attachment may be used.
• Bolsters, frames, and pads may be inspected for radiolucency prior to the operation. Placing the patient in a knee-chest position (e.g., using an Andrews table) should be avoided. Care should be taken to avoid placing the patient's spine in kyphosis during positioning of the patient.
• the vertebral pedicle is an obliquely oriented cylindrical corridor.
• the angulation varies by approximately 5 degrees per level (e.g., L1 : 5 degrees; L5: 25 degrees).
• a pre-operative fine-cut computed tomography image may be examined to determine any unique anatomy of the patient. Acquiring the pedicle in the most lateral and superior quadrant of the pedicle may be desirable to avoid the overriding facet during a minimally invasive procedure.
• a lateral entry point may allow for better screw convergence as well as less interference with the superior adjacent level facet joint.
• a targeting needle may be passed in a medial and inferior trajectory, thus following the natural pathway of the pedicle. Frequent fluoroscopic inspection in both an anteroposterior and lateral plane may ensure proper passage of the needle as the needle is inserted into vertebral bone.
• the planning sequence for a single- level stabilization may include the following four steps.
• First, an anteroposterior image may be obtained with the spinous processes centered at the target vertebral bodies.
• Vertical lines passing through midpoints of pedicles that are to receive bone fasteners may be marked on the patient. The lines do not represent skin entry points.
• the lines are markers of pedicle entry points used to estimate angles at which targeting needles to be inserted to contact the pedicles.
• sets of vertical lines may be drawn corresponding to the lateral edges of the pedicles instead of lines corresponding to the midpoints of the pedicles.
• an incision may be made in the skin between mid-pedicle lines along the vertical oblique view lines.
• the skin incision may be from about 2 cm to about 4 cm long. In some embodiments, the incision may be from about 2.5 cm to about 3 cm long. Limiting the length of the incision may enhance patient satisfaction with the procedure.
• the incisions may be pre-anesthetized with, for example, 1 % lidocaine with 1 :200,000 epinephrine.
• a long spinal needle may be used to dock on the bone entry point and inject the planned muscle path in a retrograde fashion as well. Once the incision has been made, tissue surrounding the incision may be pulled and/or stretched to allow access to a target location in a vertebra.
• a scalpel may be used to make a stab wound at the junction of an oblique view line and a mid-pedicle line.
• the scalpel may be a #1 1 scalpel.
• a targeting needle may be passed through the incision in an oblique lateral to medial trajectory towards the bony entry point defined by a lateral pedicle border line.
• the C-arm of the fluoroscope may be placed in an anteroposterior position for this maneuver.
• anteroposterior fluoroscopic images may be used to place the tip of the needle at the upper outer quadrant of the pedicle.
• the needle may be walked medially along the transverse process to the pedicle entry point.
• the needle tip may be docked by lightly tapping the tip into the bone with a mallet or other impact device to drive the tip into the bone.
• the needle tip may be docked by applying downward pressure to the targeting needle to force the tip into the bone.
• the fluoroscope may then be moved to a lateral position.
• the surgeon may correct the sagittal trajectory of the needle by moving the needle in an anterior or posterior direction to match the vector of the pedicle corridor.
• a mallet or other impact device may be used to gently advance the targeting needle into the pedicle halfway to the pedicle-vertebral body junction.
• force may be applied to the targeting needle to drive the targeting needle into the pedicle halfway to the pedicle- vertebral body junction.
• An anteroposterior image may then be obtained to confirm that the needle is approximately halfway across the pedicle in the anteroposterior view.
• the targeting needle may be advanced using a mallet.
• the needle may be pushed in without a mallet.
• the targeting needle may be advanced to the junction of the pedicle and vertebral body under lateral fluoroscopic guidance.
• the polyaxial nature of the collar may allow angulation of the sleeve relative to the bone fastener.
• Tissue surrounding the incision may be released such that the sleeve is angled toward a central location between vertebrae to be stabilized.
• the sleeve may be moved to facilitate positioning of instruments and/or to facilitate access to the adjacent vertebra that is to be stabilized.
• the sleeve may be tilted towards the adjacent pedicle so that additional length of an opening in the patient is not needed.
• the channel in the sleeve may be turned toward the adjacent pedicle that is to be stabilized with the spinal stabilization system being formed.
• the rod may be bent or shaped with a tool (e.g., a rod bender) to allow insertion of the rod through channels of sleeves with various spatial locations and/or various angular orientations.
• a tool e.g., a rod bender
• dynamic portion 104A of rod 104 may be cut to length.
• rigid portion 104B of rod 104 may be cut to length.
• both dynamic portion 104A and rigid portion 104B may be cut to length.
• a sleeve may serve as a coaxial guide to inhibit cross-threading during insertion of closure members 106.
• collars 1 12 are angled such that slots in the collars are substantially perpendicular to the rod.
• a driver may be disengaged from the closure member and removed from the sleeve.
• Adjacent Level Disease (ALD) may be prevented or slowed down in the patient by rod 104 having a dynamic portion 104A allowing movement of the third vertebra relative to the first and second vertebrae while the rigid portion 104B fuses the first and second vertebrae.

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• Health & Medical Sciences (AREA)
• Orthopedic Medicine & Surgery (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• Neurology (AREA)
• Heart & Thoracic Surgery (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
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• Surgical Instruments (AREA)
• Prostheses (AREA)

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• 2008
  • 2008-03-31 US US12/059,634 patent/US20090248077A1/en not_active Abandoned
• 2009
  • 2009-03-31 EP EP09726616A patent/EP2240101B1/fr not_active Not-in-force
  • 2009-03-31 AU AU2009231802A patent/AU2009231802A1/en not_active Abandoned
  • 2009-03-31 AT AT09726616T patent/ATE520365T1/de not_active IP Right Cessation
  • 2009-03-31 CA CA2717651A patent/CA2717651A1/fr not_active Abandoned
  • 2009-03-31 WO PCT/US2009/038977 patent/WO2009124062A1/fr not_active Ceased

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